42654 Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Rules and Regulations 

(2) The restricted area is in effect 

twenty four hours per day and seven 

days a week. 

(3) Should warranted access into the 

restricted navigation area be needed, all 

entities are to contact the Supervisor of 

Shipbuilding, Conversion and Repair, 

USN, Gulf Coast, Pascagoula, 

Mississippi, or his/her authorized 

representative on Marine 

Communication Channel 16. 

(c) Enforcement. The regulation in 

this section shall be enforced by the 

Supervisor of Shipbuilding, Conversion 

and Repair, USN, Gulf Coast, 

Pascagoula, Mississippi, and/or such 

agencies or persons as he/she may 

designate. 

Dated: July 16, 2012. 

Richard C. Lockwood, 

Chief, Operations and Regulatory, Directorate 

of Civil Works. 

[FR Doc. 2012–17780 Filed 7–19–12; 8:45 am] 

BILLING CODE 3720–58–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0458; FRL–9354–8] 

Trifloxystrobin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of trifloxystrobin 

in or on artichoke, globe. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

20, 2012. Objections and requests for 

hearings must be received on or before 

September 18, 2012, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0458, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 

8:30 a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Dominic Schuler, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0260; email address: schuler.

dominic@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0458 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 18, 2012. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0458, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 28221T, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://www.

epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of April 4, 

2012 (77 FR 20334) (FRL–9340–4), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7845) by Bayer 

CropScience, 2 TW Alexander Dr., 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.555 

be amended by establishing tolerances 

for residues of the fungicide 

trifloxystrobin, [benzeneacetic acid, 

(E,E)-a-(methoxyimino)-2-[[[[1-[3- 

(trifluoromethyl)phenyl]ethylidene] 

amino]oxy]methyl]-methyl ester], in or 

on artichoke, globe at 1.0 parts per 

million (ppm). That notice referenced a 

summary of the petition prepared by 

Bayer CropScience, the registrant, 

which is available in the docket, 

http://www.regulations.gov. 


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Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Rules and Regulations 42655 

There were no comments received in 

response to the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for trifloxystrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with trifloxystrobin follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Trifloxystrobin exhibits very low 

toxicity following single oral, dermal 

and inhalation exposures. It is a strong 

dermal sensitizer. In repeated dose tests 

in rats, the liver is the target organ for 

trifloxystrobin; toxicity is induced 

following oral and dermal exposure for 

28 days. There is no evidence of 

increased susceptibility following 

prenatal exposure to rats and rabbits 

and postnatal exposures to rats. 

Trifloxystrobin was determined not to 

be carcinogenic in mice or rats 

following long-term dietary 

administration. Trifloxystrobin is 

positive for mutagenicity in Chinese 

Hamster V79 cells, albeit at cytotoxic 

dose levels. However, trifloxystrobin is 

negative in the remaining mutagenicity 

studies. Specific information on the 

studies received and the nature of the 

adverse effects caused by trifloxystrobin 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies are discussed 

in the final rule published in the 

Federal Register of June 11, 2010 (75 FR 

33190) (FRL–8829–2), and at http://

www.regulations.gov in the document 

‘‘Trifloxystrobin. Human Health Risk 

Assessment for a Section 3 Petition 

Proposing Increased Tolerances for 

Residues in/on Field, Sweet and Pop 

Corn,’’ pp. 17–21 in docket ID number 

EPA–HQ–OPP–2009–0278. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://www.epa.

gov/pesticides/factsheets/riskassess.

htm. A summary of the toxicological 

endpoints for trifloxystrobin used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of June 11, 2010. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to trifloxystrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing trifloxystrobin tolerances in 40 

CFR 180.555. EPA assessed dietary 

exposures from trifloxystrobin in food 

as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for trifloxystrobin. In estimating acute 

dietary exposure for females 13–49 

years old, EPA conducted an analysis 

using the Dietary Exposure Evaluation 

Model (DEEM\TM\ 7.81), which used 

food consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA used 

tolerance level residues. EPA assumed 

all commodities with established or 

proposed tolerances were treated with 

trifloxystrobin. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance level residues for all 

commodities with the exception of 

apples, oranges and grapes. For these 

commodities EPA used anticipated 

residues from field residue trials. EPA 

assumed all commodities with 

established or proposed tolerances were 

treated with trifloxystrobin. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that trifloxystrobin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 


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2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for trifloxystrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

trifloxystrobin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS), and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

trifloxystrobin plus its major 

degradation product, CGA–321113 for 

the proposed artichoke, globe use are 

estimated to be 47.98 parts per billion 

(ppb) and 47.31 ppb for surface water 

for acute and chronic exposures, 

respectively. Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Trifloxystrobin is currently registered 

for the following uses that could result 

in residential exposures: Ornamentals 

and turfgrass. EPA assessed residential 

exposure under the following exposure 

scenarios: Adult post-application 

dermal exposure; and children’s postapplication dermal and/or hand to 

mouth exposure. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http://www.

epa.gov/pesticides/trac/science/

trac6a05. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found trifloxystrobin to 

share a common mechanism of toxicity 

with any other substances, and 

trifloxystrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that trifloxystrobin does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no indication of increased 

susceptibility of rat or rabbits to 

trifloxystrobin. In the prenatal 

developmental study in rats, there was 

no developmental toxicity at the limit 

dose. In the prenatal developmental 

study in rabbits, developmental toxicity 

was seen at a dose that was higher than 

the dose that caused maternal toxicity. 

In the 2-generation reproduction study, 

there was no offspring toxicity at the 

highest dose tested. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The database is complete except for 

an immunotoxicity study and an 

inhalation study. Although an 

immunotoxicity study is needed, the 

entire trifloxystrobin toxicity database 

was examined and there was no 

indication that this chemical directly 

targets the immune system. EPA does 

not believe that conducting an 

immunotoxicity study will result in a 

dose less than the points of departure 

already used in this risk assessment and 

an additional database uncertainty 

factor (UF) for potential immunotoxicity 

does not need to be applied. Regarding 

the requirement for an inhalation 

toxicity study, the Agency has increased 

its focus on the uncertainties associated 

with route-to-route extrapolation (i.e., 

the use of oral toxicity studies for 

inhalation risk assessment) and is 

presently requiring inhalation toxicity 

studies more frequently. Although an 

inhalation toxicity study is now 

required for trifloxystrobin based on 

OPP’s current weight of the evidence 

(WOE) approach, residential inhalation 

exposure is not anticipated; therefore, 

there are no uncertainties with respect 

to residential inhalation exposures to 

trifloxystrobin and no need to retain an 

additional database uncertainty factor 

for this safety finding. 

ii. There is no indication that 

trifloxystrobin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. A waiver for a subchronic 

neurotoxicity study has been granted. 

There is no evidence of neurotoxicity in 

subchronic and chronic toxicity studies 

(rats, dogs, mice), in developmental 

toxicity studies (rats, rabbits), or in a 

reproductive toxicity study (rats). There 

is no concern for neurotoxicity for 

trifloxystrobin based on the available 

database, limited findings in an acute 

neurotoxicity study, and lack of 

neurotoxicity in other fungicides of the 

strobilurin class. 

iii. There is no evidence that 

trifloxystrobin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary exposure assessment 

was unrefined, and the chronic dietary 

exposure assessment was partially 

refined, assuming 100 PCT and 

tolerance-level residues for all 

commodities except for apples, grapes, 

and oranges where the average field trial 

residues were used. By using these 

screening-level assessments with minor 

refinement, actual exposures/risks from 

residues in food will not be 

underestimated. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to trifloxystrobin in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by trifloxystrobin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 


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risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

trifloxystrobin will occupy 1.9% of the 

aPAD for females 13–49 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to trifloxystrobin 

from food and water will utilize 64% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of trifloxystrobin is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Trifloxystrobin is currently registered 

for uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to trifloxystrobin. Using the 

exposure assumptions described in this 

unit for short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

result in aggregate MOEs of 1,100 for 

adults (dermal residential + dietary food 

and drinking water exposures); 650 for 

children 1–2 years (dermal residential + 

dietary food and drinking water 

exposures); and 130 for children 1–2 

years (incidental oral residential + 

dietary food and drinking water 

exposures). Because EPA’s level of 

concern for trifloxystrobin is a MOE of 

100 or less, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Trifloxystrobin is not expected to pose 

an intermediate-term risk based on a 

short soil half-life (approximately 2 

days). 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

chemical name is not expected to pose 

a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

trifloxystrobin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with nitrogen 

phosphorus detection (GC/NPD), 

Method AG–659A and liquid 

chromatography with tandem mass 

spectrometry detection (LC/MS/MS), 

Method No. 200177) is available to 

enforce the tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for trifloxystrobin on artichoke, globe. 

Therefore, international harmonization 

is not an issue. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of trifloxystrobin, 

[benzeneacetic acid, (E,E)-a- 

(methoxyimino)-2-[[[[1-[3- 

(trifluoromethyl)phenyl]ethylidene] 

amino]oxy]methyl]-methyl ester], in or 

on artichoke, globe at 1.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). Since tolerances and exemptions 

that are established on the basis of a 

petition under FFDCA section 408(d), 

such as the tolerance in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 


tkelley on DSK3SPTVN1PROD with RULES
42658 Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Rules and Regulations 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 11, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.555 is amended by 

alphabetically adding ‘‘Artichoke, 

globe’’ to the table in paragraph (a) to 

read as follows: 

§ 180.555 Trifloxystrobin; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Artichoke, globe ........................ 1.0 

* * * * * 

* * * * * 

[FR Doc. 2012–17630 Filed 7–19–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 156 

[CMS–9965–F] 

RIN 0938–AR36 

Patient Protection and Affordable Care 

Act; Data Collection To Support 

Standards Related to Essential Health 

Benefits; Recognition of Entities for 

the Accreditation of Qualified Health 

Plans 

AGENCY: Department of Health and 

Human Services. 

ACTION: Final rule. 

SUMMARY: This final rule establishes 

data collection standards necessary to 

implement aspects of section 1302 of 

the Patient Protection and Affordable 

Care Act (Affordable Care Act), which 

directs the Secretary of Health and 

Human Services to define essential 

health benefits. This final rule outlines 

the data on applicable plans to be 

collected from certain issuers to support 

the definition of essential health 

benefits. This final rule also establishes 

a process for the recognition of 

accrediting entities for purposes of 

certification of qualified health plans. 

DATES: Effective Date: These regulations 

are effective on August 20, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Adam Block at (410) 786–1698, for 

matters related to essential health 

benefits data collection. 

Deborah Greene at (301) 492–4293, for 

matters related to accreditation of 

qualified health plans. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Beginning in 2014, all nongrandfathered health plans in the 

individual and small group market, and 

other plans will cover the essential 

health benefits (EHB), as defined by the 

Secretary of Health and Human Services 

(the Secretary). The Affordable Care Act 

directs that the EHB reflect the scope of 

benefits covered by a typical employer 

plan and cover at least the following 10 

general categories of items and services: 

Ambulatory patient services; emergency 

services; hospitalization; maternity and 

newborn care; mental health and 

substance use disorder services, 

including behavioral health treatment; 

prescription drugs; rehabilitative and 

habilitative services and devices; 

laboratory services; preventive and 

wellness services and chronic disease 

management; and pediatric services, 

including oral and vision care. EHB will 

promote predictability for consumers 

who purchase coverage in these 

markets, facilitate comparison across 

health plans, and ensure that individual 

and small group subscribers have the 

same access to the same scope of 

benefits provided under a typical 

employer plan. 

This final rule includes data reporting 

standards for health plans that represent 

potential State-specific benchmark 

plans. Specifically, the final rule 

establishes that issuers of the largest 

three small group market products in 

each state report information on covered 

benefits. 

In addition, this rule establishes the 

first phase of a two-phased approach for 

recognizing accrediting entities to 

implement the standards established 

under the Affordable Care Act for 

qualified health plans (QHPs) to be 

accredited on the basis of local 

performance by an accrediting entity 

recognized by the Secretary on a 

timeline established by the Exchange 

and addresses some data sharing and 

performance requirements of the 

recognized accrediting entities. In phase 

one, the National Committee for Quality 

Assurance (NCQA) and URAC are 

recognized as accrediting entities on an 

interim basis. In phase two, a criteriabased review process will be adopted 

through future rulemaking. 

I. Background 

Section 2707 of the Public Health 

Service Act, as added by section 1201 of 

the Affordable Care Act, directs that, for 

plan years beginning on or after January 

1, 2014, health insurance issuers 

offering non-grandfathered plans in the 

individual or small group market ensure 

such coverage includes EHB as 

described in section 1302(a) of the 

Affordable Care Act. Section 1302 of the 

Affordable Care Act provides for the 

establishment of EHB, to be defined by 

the Secretary. The law also directs that 

EHB reflect the scope of benefits 

covered by a typical employer plan and 

cover at least the 10 general categories 

of items and services previously listed. 

Section 1302(b)(4) of the Affordable 

Care Act further establishes that the 

Secretary define EHB such that it: 

• Sets an appropriate balance among 

the 10 general categories; 

• Does not discriminate based on age, 

disability, or expected length of life; 

• Takes into account the health care 

needs of diverse segments of the 

population; and 

• Does not allow denials of essential 

benefits based on age, life expectancy, 

disability, or degree of medical 

dependency and quality of life. 

Section 1302(b)(4) of the Affordable 

Care Act further directs the Secretary to 


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